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Serving 500+ biopharmaceutical companies globally:

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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204209

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NDA 204209 describes ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE, which is a drug marketed by Larken Labs Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE profile page.

The generic ingredient in ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

Summary for NDA: 204209

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204209

Ingredient-typeXanthines
Mechanism of ActionFull Opioid Agonists
Physiological EffectCentral Nervous System Stimulation

Suppliers and Packaging for NDA: 204209

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
acetaminophen; caffeine; dihydrocodeine bitartrate
TABLET;ORAL 204209 ANDA Larken Laboratories Inc. 68047-720 68047-720-01 100 TABLET in 1 BOTTLE (68047-720-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;30MG;16MG
Approval Date:Sep 30, 2016TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
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